Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial
Journal
Stroke and vascular neurology
Journal Volume
7
Journal Issue
2
Pages
158-165
Date Issued
2022
Author(s)
Yassi N.
Zhao H.
Churilov L.
Campbell B.C.V.
Wu T.
Ma H.
Cheung A.
Kleinig T.
Brown H.
Choi P.
Ranta A.
Wang H.-K.
Cloud G.C.
Grimley R.
Shah D.
Spratt N.
Cho D.-Y.
Mahawish K.
Sanders L.
Worthington J.
Clissold B.
Meretoja A.
Yogendrakumar V.
Ton M.D.
Dang D.P.
Phuong N.T.M.
Nguyen H.-T.
Hsu C.Y.
Sharma G.
Mitchell P.J.
Yan B.
Parsons M.W.
Levi C.
Donnan G.A.
Davis S.M.
Abstract
RATIONALE: Haematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth. METHODS AND DESIGN: Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework. HYPOTHESIS: In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo. SAMPLE SIZE ESTIMATES: A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients. INTERVENTION: Participants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo. PRIMARY EFFICACY MEASURE: The primary efficacy measure is the proportion of patients with haematoma growth by 24��6 hours, defined as either ?33% relative increase or ?6 mL absolute increase in haematoma volume between baseline and follow-up CT scan. DISCUSSION: We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.
SDGs
Type
journal article